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NCT02737722 · ClinicalTrials.gov registry record · Phase 1
Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus
A Phase 1 study of Diabetic Foot Infections, sponsored by Lakewood-Amedex.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 3
- Study locations
NCT02737722: Completed Phase 1 study of Diabetic Foot Infections, sponsored by Lakewood-Amedex.
NCT02737722 is a Phase 1 study of Diabetic Foot Infections that has completed, run by Lakewood-Amedex. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02737722, a Phase 1 study of Diabetic Foot Infections, has completed, sponsored by Lakewood-Amedex.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 3
- Study locations
Study Summary
Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS score of 0 to 3 and DFI wound score of 1 to 3.
Primary Outcome
The severity of each adverse event, as judged by the investigator, was graded according to the CTCAE v4.02. Treatment-emergent adverse events are defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bisphosphocin Nu-3
Study Locations (3)
California
- Center for Clinical Research, Inc. - San Francisco
Florida
- Journey Research, Inc. - Oldsmar
Tennessee
- Clinical Research Solutions - Franklin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2016-04 |
| Est. Completion | 2018-02 |
| Phase | Phase 1 |
What the finished NCT02737722 record still lists
NCT02737722 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Diabetic Foot Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02737722 reports a single indexed study location in California, Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT02737722 about?
NCT02737722 is a clinical study titled "Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus". Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS score of 0 to 3 and DFI wound score of 1 to 3.
What is the current status of trial NCT02737722?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2016-04. Estimated completion is 2018-02.
What conditions does trial NCT02737722 study?
This clinical trial studies the following conditions: Diabetic Foot Infections.
What interventions are being tested in trial NCT02737722?
The interventions under investigation include: Placebo (DRUG), Bisphosphocin Nu-3 (DRUG).
Who is sponsoring clinical trial NCT02737722?
This trial is sponsored by Lakewood-Amedex, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02737722 being conducted?
This trial has 3 study locations across California, Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02737722's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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